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MACRA advice: Do the MIPS bare minimum this year
ORLANDO – Confused about what MACRA, MIPS, and APMs mean for you and your practice this year?
Clifford Lober, MD, offered some very simple advice at the annual meeting of the American Academy of Dermatology: “If you take nothing else from this annual meeting – not this session, but the whole meeting – submit one quality measure or one improvement activity or the required advancing care information base measures – one time, on one patient” to the MIPS program, Dr. Lober said. “If you do that, you will save 4% of your Medicare payments in 2019.”*
MIPS is a system of bonuses and penalties based on data the Medicare program started collecting on Jan. 1, 2017; it incorporates the legacy quality measure reporting systems including the Physician Quality Reporting System, meaningful use, and the value-based modifier program, said Dr. Lober, a dermatologist in private practice in Kissimmee, Fla.
Based on feedback from physicians and other stakeholders, Medicare announced last fall that physicians could “pick their pace” as to how they wanted to report data to MIPS in 2017, the first baseline year of the program. They could:
- Choose to not participate. These physicians will see an automatic 4% reduction in their Medicare payments in 2019.
- Test QPP. Report on one quality measure or improvement activity for one patient. Of note: This information does not have to be submitted electronically; paper submission is okay. These physicians will avoid the 4% Medicare pay cut.
- Participate for part of the year. These physicians will report for 90 consecutive days of their choice on more than one quality measure, more than one improvement activity, or more than the required measures in the advancing care information performance category. Reporting must start before Oct. 2, 2017. These physicians may earn a pay increase.*
- Participate for the full year. Submit a full year of data to Medicare. These physicians may get a pay increase.
Dr. Lober said pointedly, “The first choice – doing nothing – is the dumbest move you could make.”
He also noted that the CMS regulations say verbatim that “positive adjustments are based on data on the performance information submitted, not the amount of information or the length of time submitted.”
A few physicians and other clinicians are exempted from the QPP for 2017. Those who are in their first year of participating in Medicare Part B are exempt, as are those who bill less than $30,000 or have fewer than 100 Medicare patients.*
“The low-value exemption alone, CMS actuaries think, will exempt 32.5% of clinicians in the United States – a huge exemption,” Dr. Lober said, adding that when it comes to dermatologists, it’s estimated that about 18.3% will be exempt from MIPS.
Despite the new political landscape in Washington, Dr. Lober said that he does not think MACRA will go away.
“One of the things I want to say out front is, what is the likelihood of MACRA being repealed?” he said. “Somewhere between slim and none or even none and none. It was supported by both Democrats and Republicans and I think it’s here to stay. It might be modified, but it’s here to stay.”
He urged physicians to reach out to CMS if they have comments about the MIPS, APMs, and the Quality Payment Program, noting that despite the formal comment period being closed, agency officials have been receptive to comments and suggestions.
*This article was updated on March 13, 2017 at 3:30 p.m.
dfulton@frontlinemedcom.com
On Twitter @denisefulton
ORLANDO – Confused about what MACRA, MIPS, and APMs mean for you and your practice this year?
Clifford Lober, MD, offered some very simple advice at the annual meeting of the American Academy of Dermatology: “If you take nothing else from this annual meeting – not this session, but the whole meeting – submit one quality measure or one improvement activity or the required advancing care information base measures – one time, on one patient” to the MIPS program, Dr. Lober said. “If you do that, you will save 4% of your Medicare payments in 2019.”*
MIPS is a system of bonuses and penalties based on data the Medicare program started collecting on Jan. 1, 2017; it incorporates the legacy quality measure reporting systems including the Physician Quality Reporting System, meaningful use, and the value-based modifier program, said Dr. Lober, a dermatologist in private practice in Kissimmee, Fla.
Based on feedback from physicians and other stakeholders, Medicare announced last fall that physicians could “pick their pace” as to how they wanted to report data to MIPS in 2017, the first baseline year of the program. They could:
- Choose to not participate. These physicians will see an automatic 4% reduction in their Medicare payments in 2019.
- Test QPP. Report on one quality measure or improvement activity for one patient. Of note: This information does not have to be submitted electronically; paper submission is okay. These physicians will avoid the 4% Medicare pay cut.
- Participate for part of the year. These physicians will report for 90 consecutive days of their choice on more than one quality measure, more than one improvement activity, or more than the required measures in the advancing care information performance category. Reporting must start before Oct. 2, 2017. These physicians may earn a pay increase.*
- Participate for the full year. Submit a full year of data to Medicare. These physicians may get a pay increase.
Dr. Lober said pointedly, “The first choice – doing nothing – is the dumbest move you could make.”
He also noted that the CMS regulations say verbatim that “positive adjustments are based on data on the performance information submitted, not the amount of information or the length of time submitted.”
A few physicians and other clinicians are exempted from the QPP for 2017. Those who are in their first year of participating in Medicare Part B are exempt, as are those who bill less than $30,000 or have fewer than 100 Medicare patients.*
“The low-value exemption alone, CMS actuaries think, will exempt 32.5% of clinicians in the United States – a huge exemption,” Dr. Lober said, adding that when it comes to dermatologists, it’s estimated that about 18.3% will be exempt from MIPS.
Despite the new political landscape in Washington, Dr. Lober said that he does not think MACRA will go away.
“One of the things I want to say out front is, what is the likelihood of MACRA being repealed?” he said. “Somewhere between slim and none or even none and none. It was supported by both Democrats and Republicans and I think it’s here to stay. It might be modified, but it’s here to stay.”
He urged physicians to reach out to CMS if they have comments about the MIPS, APMs, and the Quality Payment Program, noting that despite the formal comment period being closed, agency officials have been receptive to comments and suggestions.
*This article was updated on March 13, 2017 at 3:30 p.m.
dfulton@frontlinemedcom.com
On Twitter @denisefulton
ORLANDO – Confused about what MACRA, MIPS, and APMs mean for you and your practice this year?
Clifford Lober, MD, offered some very simple advice at the annual meeting of the American Academy of Dermatology: “If you take nothing else from this annual meeting – not this session, but the whole meeting – submit one quality measure or one improvement activity or the required advancing care information base measures – one time, on one patient” to the MIPS program, Dr. Lober said. “If you do that, you will save 4% of your Medicare payments in 2019.”*
MIPS is a system of bonuses and penalties based on data the Medicare program started collecting on Jan. 1, 2017; it incorporates the legacy quality measure reporting systems including the Physician Quality Reporting System, meaningful use, and the value-based modifier program, said Dr. Lober, a dermatologist in private practice in Kissimmee, Fla.
Based on feedback from physicians and other stakeholders, Medicare announced last fall that physicians could “pick their pace” as to how they wanted to report data to MIPS in 2017, the first baseline year of the program. They could:
- Choose to not participate. These physicians will see an automatic 4% reduction in their Medicare payments in 2019.
- Test QPP. Report on one quality measure or improvement activity for one patient. Of note: This information does not have to be submitted electronically; paper submission is okay. These physicians will avoid the 4% Medicare pay cut.
- Participate for part of the year. These physicians will report for 90 consecutive days of their choice on more than one quality measure, more than one improvement activity, or more than the required measures in the advancing care information performance category. Reporting must start before Oct. 2, 2017. These physicians may earn a pay increase.*
- Participate for the full year. Submit a full year of data to Medicare. These physicians may get a pay increase.
Dr. Lober said pointedly, “The first choice – doing nothing – is the dumbest move you could make.”
He also noted that the CMS regulations say verbatim that “positive adjustments are based on data on the performance information submitted, not the amount of information or the length of time submitted.”
A few physicians and other clinicians are exempted from the QPP for 2017. Those who are in their first year of participating in Medicare Part B are exempt, as are those who bill less than $30,000 or have fewer than 100 Medicare patients.*
“The low-value exemption alone, CMS actuaries think, will exempt 32.5% of clinicians in the United States – a huge exemption,” Dr. Lober said, adding that when it comes to dermatologists, it’s estimated that about 18.3% will be exempt from MIPS.
Despite the new political landscape in Washington, Dr. Lober said that he does not think MACRA will go away.
“One of the things I want to say out front is, what is the likelihood of MACRA being repealed?” he said. “Somewhere between slim and none or even none and none. It was supported by both Democrats and Republicans and I think it’s here to stay. It might be modified, but it’s here to stay.”
He urged physicians to reach out to CMS if they have comments about the MIPS, APMs, and the Quality Payment Program, noting that despite the formal comment period being closed, agency officials have been receptive to comments and suggestions.
*This article was updated on March 13, 2017 at 3:30 p.m.
dfulton@frontlinemedcom.com
On Twitter @denisefulton
AT AAD 17
Physicians need to take hyperhidrosis in teens seriously
ORLANDO – Not quite a fifth of teens experience excessive, uncontrollable sweating, according to the results of an online survey presented during this year’s annual American Academy of Dermatology.
Because nearly 70% of teens who reported the condition said it interferes with their activities of daily living, late-breaking research presenter, Adelaide A. Hebert, MD, chief of pediatric dermatology at the University of Texas, Houston, said it was time medical schools paid more attention to it.
For the study, Dr. Hebert and her colleagues online-surveyed 1,000 adolescents between 12 and 17 years who meet the accepted diagnostic criteria for primary focal hyperhidrosis. An analysis of the 981 surveys that were complete showed that 17.1% of respondents experienced excessive, uncontrollable sweating and that 68.6% of these reported the sweating was moderate or major, impairing their normal functioning.
The average age of onset for the condition was 11 years, although more than a quarter of respondents said their sweating began at age 10 years. Nearly all those surveyed said they sweat from at least two focal areas, with five areas being the average number of focal areas.
Adolescence is when hyperhidrosis begins for many adults with the condition, yet few if any data exist regarding the condition in this age group, according to Dr. Hebert. “We have to figure out what is going on so maybe we can make a difference later.”
wmcknight@frontlinemedcom.com
On Twitter @whitneymcknight
ORLANDO – Not quite a fifth of teens experience excessive, uncontrollable sweating, according to the results of an online survey presented during this year’s annual American Academy of Dermatology.
Because nearly 70% of teens who reported the condition said it interferes with their activities of daily living, late-breaking research presenter, Adelaide A. Hebert, MD, chief of pediatric dermatology at the University of Texas, Houston, said it was time medical schools paid more attention to it.
For the study, Dr. Hebert and her colleagues online-surveyed 1,000 adolescents between 12 and 17 years who meet the accepted diagnostic criteria for primary focal hyperhidrosis. An analysis of the 981 surveys that were complete showed that 17.1% of respondents experienced excessive, uncontrollable sweating and that 68.6% of these reported the sweating was moderate or major, impairing their normal functioning.
The average age of onset for the condition was 11 years, although more than a quarter of respondents said their sweating began at age 10 years. Nearly all those surveyed said they sweat from at least two focal areas, with five areas being the average number of focal areas.
Adolescence is when hyperhidrosis begins for many adults with the condition, yet few if any data exist regarding the condition in this age group, according to Dr. Hebert. “We have to figure out what is going on so maybe we can make a difference later.”
wmcknight@frontlinemedcom.com
On Twitter @whitneymcknight
ORLANDO – Not quite a fifth of teens experience excessive, uncontrollable sweating, according to the results of an online survey presented during this year’s annual American Academy of Dermatology.
Because nearly 70% of teens who reported the condition said it interferes with their activities of daily living, late-breaking research presenter, Adelaide A. Hebert, MD, chief of pediatric dermatology at the University of Texas, Houston, said it was time medical schools paid more attention to it.
For the study, Dr. Hebert and her colleagues online-surveyed 1,000 adolescents between 12 and 17 years who meet the accepted diagnostic criteria for primary focal hyperhidrosis. An analysis of the 981 surveys that were complete showed that 17.1% of respondents experienced excessive, uncontrollable sweating and that 68.6% of these reported the sweating was moderate or major, impairing their normal functioning.
The average age of onset for the condition was 11 years, although more than a quarter of respondents said their sweating began at age 10 years. Nearly all those surveyed said they sweat from at least two focal areas, with five areas being the average number of focal areas.
Adolescence is when hyperhidrosis begins for many adults with the condition, yet few if any data exist regarding the condition in this age group, according to Dr. Hebert. “We have to figure out what is going on so maybe we can make a difference later.”
wmcknight@frontlinemedcom.com
On Twitter @whitneymcknight
AT AAD 17
Key clinical point:
Major finding: Hyperhidrosis is common in 17% of teens surveyed; 69% of these reported hyperhidrosis interferes with activities of daily living.
Data source: Online survey of 1,000 U.S. teens between 12 and 17 years who reported excessive, uncontrollable sweating.
Disclosures: Dr. Hebert received a grant from GlaxoSmithKline for this study. She is also a board member of the International Hyperhidrosis Society.
Teletriage app reduced skin specialty care wait times
ORLANDO – A teletriage app significantly reduced the time between triage and evaluation by a dermatologist, helping a volunteer-staffed clinic for the uninsured see more patients and improve rates of accurate diagnosis and treatment.
Peter Chansky, a medical student at the University of Pennsylvania, Philadelphia, presented the data on a study of the app during a late-breaking research session at this year’s annual meeting of the American Academy of Dermatology.
The teletriage app AccessDerm, which is free to all AAD members, uses a photo of the dermatological condition, along with basic clinical and demographic information. The investigators found that with the app, the mean time from referral to teledermatology response was 1.4 days vs. 13.4 days for waiting to be seen in the next dermatology clinic (P less than .0001). Additionally, because the app requires the referring physicians to enter a differential diagnosis and a suggested treatment plan, it was established that diagnoses improved with teledermatology. Compared with self-reported primary care provider plans, the app led to an altered course of treatment in 95% of cases.
In all, 70% of cases were triaged via teledermatology without the need for an in-person evaluation, resulting in an average of 1.4 out of 8 appointments being saved monthly. This allowed the clinic to treat 18% more patients who needed in-person care, according to Mr. Chansky.
“Teletriage can be easily implemented in an underserved clinical setting, and provides an opportunity for dermatologists to make a significant and meaningful impact on the health care and outcomes of underserved populations,” Mr. Chansky said.
wmcknight@frontlinemedcom.com
On Twitter @whitneymcknight
ORLANDO – A teletriage app significantly reduced the time between triage and evaluation by a dermatologist, helping a volunteer-staffed clinic for the uninsured see more patients and improve rates of accurate diagnosis and treatment.
Peter Chansky, a medical student at the University of Pennsylvania, Philadelphia, presented the data on a study of the app during a late-breaking research session at this year’s annual meeting of the American Academy of Dermatology.
The teletriage app AccessDerm, which is free to all AAD members, uses a photo of the dermatological condition, along with basic clinical and demographic information. The investigators found that with the app, the mean time from referral to teledermatology response was 1.4 days vs. 13.4 days for waiting to be seen in the next dermatology clinic (P less than .0001). Additionally, because the app requires the referring physicians to enter a differential diagnosis and a suggested treatment plan, it was established that diagnoses improved with teledermatology. Compared with self-reported primary care provider plans, the app led to an altered course of treatment in 95% of cases.
In all, 70% of cases were triaged via teledermatology without the need for an in-person evaluation, resulting in an average of 1.4 out of 8 appointments being saved monthly. This allowed the clinic to treat 18% more patients who needed in-person care, according to Mr. Chansky.
“Teletriage can be easily implemented in an underserved clinical setting, and provides an opportunity for dermatologists to make a significant and meaningful impact on the health care and outcomes of underserved populations,” Mr. Chansky said.
wmcknight@frontlinemedcom.com
On Twitter @whitneymcknight
ORLANDO – A teletriage app significantly reduced the time between triage and evaluation by a dermatologist, helping a volunteer-staffed clinic for the uninsured see more patients and improve rates of accurate diagnosis and treatment.
Peter Chansky, a medical student at the University of Pennsylvania, Philadelphia, presented the data on a study of the app during a late-breaking research session at this year’s annual meeting of the American Academy of Dermatology.
The teletriage app AccessDerm, which is free to all AAD members, uses a photo of the dermatological condition, along with basic clinical and demographic information. The investigators found that with the app, the mean time from referral to teledermatology response was 1.4 days vs. 13.4 days for waiting to be seen in the next dermatology clinic (P less than .0001). Additionally, because the app requires the referring physicians to enter a differential diagnosis and a suggested treatment plan, it was established that diagnoses improved with teledermatology. Compared with self-reported primary care provider plans, the app led to an altered course of treatment in 95% of cases.
In all, 70% of cases were triaged via teledermatology without the need for an in-person evaluation, resulting in an average of 1.4 out of 8 appointments being saved monthly. This allowed the clinic to treat 18% more patients who needed in-person care, according to Mr. Chansky.
“Teletriage can be easily implemented in an underserved clinical setting, and provides an opportunity for dermatologists to make a significant and meaningful impact on the health care and outcomes of underserved populations,” Mr. Chansky said.
wmcknight@frontlinemedcom.com
On Twitter @whitneymcknight
AT AAD 17
VIDEO: Don’t overlook psychosocial concerns of vitiligo patients
ORLANDO – There are ways to assess the psychosocial needs of your patients with vitiligo, even if you don’t believe you have the necessary skills to do a complete mental health work-up, according to Seemal R. Desai, MD.
In an interview recorded at this year’s annual meeting of the American Academy of Dermatology, Dr. Desai, an assistant clinical professor of dermatology at the University of Texas, Dallas, shares his ideas for how to have casual conversations with patients that can help reveal important clues to psychosocial stress patients with this serious medical skin condition might be facing.
“There are subtle clues to look for to know that these patients are uncomfortable with others seeing their skin,” says Dr. Desai.
In the video interview, he also covers taking a multidisciplinary approach to caring for these patients, what treatments are available to those who are suffering psychosocial stress after having failed several interventions, and how patients from many Asian and African counties are especially at risk for ostracization.
“It’s important to let your patients know that you understand this is really affecting them psychosocially, and that you care,” says Dr. Desai.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
wmcknight@frontlinemedcom.com
On Twitter @whitneymcknight
ORLANDO – There are ways to assess the psychosocial needs of your patients with vitiligo, even if you don’t believe you have the necessary skills to do a complete mental health work-up, according to Seemal R. Desai, MD.
In an interview recorded at this year’s annual meeting of the American Academy of Dermatology, Dr. Desai, an assistant clinical professor of dermatology at the University of Texas, Dallas, shares his ideas for how to have casual conversations with patients that can help reveal important clues to psychosocial stress patients with this serious medical skin condition might be facing.
“There are subtle clues to look for to know that these patients are uncomfortable with others seeing their skin,” says Dr. Desai.
In the video interview, he also covers taking a multidisciplinary approach to caring for these patients, what treatments are available to those who are suffering psychosocial stress after having failed several interventions, and how patients from many Asian and African counties are especially at risk for ostracization.
“It’s important to let your patients know that you understand this is really affecting them psychosocially, and that you care,” says Dr. Desai.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
wmcknight@frontlinemedcom.com
On Twitter @whitneymcknight
ORLANDO – There are ways to assess the psychosocial needs of your patients with vitiligo, even if you don’t believe you have the necessary skills to do a complete mental health work-up, according to Seemal R. Desai, MD.
In an interview recorded at this year’s annual meeting of the American Academy of Dermatology, Dr. Desai, an assistant clinical professor of dermatology at the University of Texas, Dallas, shares his ideas for how to have casual conversations with patients that can help reveal important clues to psychosocial stress patients with this serious medical skin condition might be facing.
“There are subtle clues to look for to know that these patients are uncomfortable with others seeing their skin,” says Dr. Desai.
In the video interview, he also covers taking a multidisciplinary approach to caring for these patients, what treatments are available to those who are suffering psychosocial stress after having failed several interventions, and how patients from many Asian and African counties are especially at risk for ostracization.
“It’s important to let your patients know that you understand this is really affecting them psychosocially, and that you care,” says Dr. Desai.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
wmcknight@frontlinemedcom.com
On Twitter @whitneymcknight
EXPERT ANALYSIS FROM AAD 17
CIMPASI-1 and -2 show certolizumab pegol benefits patients with severe plaque psoriasis
ORLANDO – Results from two phase III trials indicated the tumor necrosis factor alpha inhibitor certolizumab pegol led to significant improvements in moderate to severe chronic plaque psoriasis, compared with placebo, according to an oral presentation at this year’s annual Academy of Dermatology Meeting.
Across the CIMPASI-1 and CIMPASI-2 trials, at 16 weeks, both certolizumab pegol (Cimzia) 400 mg and 200 mg, administered subcutaneously every 2 weeks in groups of patients with moderate to severe chronic plaque psoriasis, demonstrated statistically significant, clinically meaningful improvements in Psoriasis Area and Severity Index (PASI) scores, and on the Physician Global Assessment (PGA) scores, when compared with placebo. The data were presented by Alice B. Gottlieb, MD, PhD, professor of dermatology at New York Medical College, Valhalla. Certolizumab pegol currently is approved in the United States for use in psoriatic arthritis, but not for psoriasis.
In CIMPASI-1, 234 mostly white male patients in their mid-40s who had moderate to severe chronic plaque psoriasis were randomly assigned to one of three groups. There were 88 participants in the arm given 400 mg every 2 weeks at weeks 0, 2, and 4; 95 given 200 mg at weeks 0, 2, and 4; and 51 given placebo. At week 16, the percentage of patients who achieved a PASI 75 was 75.8% in the first group, 66.5% in the second, and 6.5% for placebo. A PGA scale improvement of at least two points over baseline toward a final score of clear or almost clear skin at week 16 was 57.9% for group 1, 47.0% for the second group, and 4.2% for placebo.
Also at week 16, the percentage of patients who achieved a PASI 90 was 43.6% in the 400 mg dose group, 35.8% in the 200 mg dose group, and 0.4% in the placebo group.
In CIMPASI-2, 227 mostly white patients with moderate to severe chronic plaque psoriasis, most of whom were in their mid-40s, evenly distributed across the sexes, were randomly assigned to one of three groups. There were 87 participants in the 400 mg every 2 weeks at weeks 0, 2, and 4 group; 91 in the 200 mg every 2 weeks at weeks 0, 2, and 4 arm, and 49 in the placebo group. At week 16, 82.6% of patients in the first group and 81.4% in the second group had a PASI 75, compared with 11.6% of the placebo group. Also at 16 weeks, a PGA scale improvement of at least two points over baseline toward a final score of clear or almost clear skin at week 16 was 71.6% for group 1, 66.8% for the second group, and 2.0% for placebo. At week 16, 55.4% of patients receiving the 400 mg dose had a PASI 90, as did 52.6% of patients receiving the 200 mg dose every 2 weeks, compared with only 4.5% of the placebo group.
Additionally, Dr. Gottlieb said that at week 16, patients in the 400-mg and 200-mg groups showed significant improvements over baseline Dermatology Life Quality Index (DLQI) average scores, compared with placebo: a 10.2 decrease in the 400-mg group and a 9.3 decrease in the 200-mg group, compared with a 3.3 decrease in the placebo arm (P less than .001) in the CIMPASI-1 study. In the CIMPASI-2 study at week 16, there was a drop of 10.0 DLQI in average scores in the 400-mg group, 10.4 in the 200-mg group, and an average drop of only 3.8 in controls (P less than .001).
Dr. Gottlieb, who disclosed that her mother suffers from severe plaque psoriasis, told the audience that the patient improvements were on par with those seen with infliximab, which she said was “the best anti–TNF alpha in the pack to date, and that’s an intravenous drug. These are impressive drops in the DLQI.”
Adverse events were, said Dr. Gottlieb, “a whole lot of nothing. There’s nothing that stands out.” She said there were no cases of tuberculosis, one case of vulvovaginal candidiasis, and equal distribution of herpes zoster across the study.
wmcknight@frontlinemedcom.com
On Twitter @whitneymcknight
ORLANDO – Results from two phase III trials indicated the tumor necrosis factor alpha inhibitor certolizumab pegol led to significant improvements in moderate to severe chronic plaque psoriasis, compared with placebo, according to an oral presentation at this year’s annual Academy of Dermatology Meeting.
Across the CIMPASI-1 and CIMPASI-2 trials, at 16 weeks, both certolizumab pegol (Cimzia) 400 mg and 200 mg, administered subcutaneously every 2 weeks in groups of patients with moderate to severe chronic plaque psoriasis, demonstrated statistically significant, clinically meaningful improvements in Psoriasis Area and Severity Index (PASI) scores, and on the Physician Global Assessment (PGA) scores, when compared with placebo. The data were presented by Alice B. Gottlieb, MD, PhD, professor of dermatology at New York Medical College, Valhalla. Certolizumab pegol currently is approved in the United States for use in psoriatic arthritis, but not for psoriasis.
In CIMPASI-1, 234 mostly white male patients in their mid-40s who had moderate to severe chronic plaque psoriasis were randomly assigned to one of three groups. There were 88 participants in the arm given 400 mg every 2 weeks at weeks 0, 2, and 4; 95 given 200 mg at weeks 0, 2, and 4; and 51 given placebo. At week 16, the percentage of patients who achieved a PASI 75 was 75.8% in the first group, 66.5% in the second, and 6.5% for placebo. A PGA scale improvement of at least two points over baseline toward a final score of clear or almost clear skin at week 16 was 57.9% for group 1, 47.0% for the second group, and 4.2% for placebo.
Also at week 16, the percentage of patients who achieved a PASI 90 was 43.6% in the 400 mg dose group, 35.8% in the 200 mg dose group, and 0.4% in the placebo group.
In CIMPASI-2, 227 mostly white patients with moderate to severe chronic plaque psoriasis, most of whom were in their mid-40s, evenly distributed across the sexes, were randomly assigned to one of three groups. There were 87 participants in the 400 mg every 2 weeks at weeks 0, 2, and 4 group; 91 in the 200 mg every 2 weeks at weeks 0, 2, and 4 arm, and 49 in the placebo group. At week 16, 82.6% of patients in the first group and 81.4% in the second group had a PASI 75, compared with 11.6% of the placebo group. Also at 16 weeks, a PGA scale improvement of at least two points over baseline toward a final score of clear or almost clear skin at week 16 was 71.6% for group 1, 66.8% for the second group, and 2.0% for placebo. At week 16, 55.4% of patients receiving the 400 mg dose had a PASI 90, as did 52.6% of patients receiving the 200 mg dose every 2 weeks, compared with only 4.5% of the placebo group.
Additionally, Dr. Gottlieb said that at week 16, patients in the 400-mg and 200-mg groups showed significant improvements over baseline Dermatology Life Quality Index (DLQI) average scores, compared with placebo: a 10.2 decrease in the 400-mg group and a 9.3 decrease in the 200-mg group, compared with a 3.3 decrease in the placebo arm (P less than .001) in the CIMPASI-1 study. In the CIMPASI-2 study at week 16, there was a drop of 10.0 DLQI in average scores in the 400-mg group, 10.4 in the 200-mg group, and an average drop of only 3.8 in controls (P less than .001).
Dr. Gottlieb, who disclosed that her mother suffers from severe plaque psoriasis, told the audience that the patient improvements were on par with those seen with infliximab, which she said was “the best anti–TNF alpha in the pack to date, and that’s an intravenous drug. These are impressive drops in the DLQI.”
Adverse events were, said Dr. Gottlieb, “a whole lot of nothing. There’s nothing that stands out.” She said there were no cases of tuberculosis, one case of vulvovaginal candidiasis, and equal distribution of herpes zoster across the study.
wmcknight@frontlinemedcom.com
On Twitter @whitneymcknight
ORLANDO – Results from two phase III trials indicated the tumor necrosis factor alpha inhibitor certolizumab pegol led to significant improvements in moderate to severe chronic plaque psoriasis, compared with placebo, according to an oral presentation at this year’s annual Academy of Dermatology Meeting.
Across the CIMPASI-1 and CIMPASI-2 trials, at 16 weeks, both certolizumab pegol (Cimzia) 400 mg and 200 mg, administered subcutaneously every 2 weeks in groups of patients with moderate to severe chronic plaque psoriasis, demonstrated statistically significant, clinically meaningful improvements in Psoriasis Area and Severity Index (PASI) scores, and on the Physician Global Assessment (PGA) scores, when compared with placebo. The data were presented by Alice B. Gottlieb, MD, PhD, professor of dermatology at New York Medical College, Valhalla. Certolizumab pegol currently is approved in the United States for use in psoriatic arthritis, but not for psoriasis.
In CIMPASI-1, 234 mostly white male patients in their mid-40s who had moderate to severe chronic plaque psoriasis were randomly assigned to one of three groups. There were 88 participants in the arm given 400 mg every 2 weeks at weeks 0, 2, and 4; 95 given 200 mg at weeks 0, 2, and 4; and 51 given placebo. At week 16, the percentage of patients who achieved a PASI 75 was 75.8% in the first group, 66.5% in the second, and 6.5% for placebo. A PGA scale improvement of at least two points over baseline toward a final score of clear or almost clear skin at week 16 was 57.9% for group 1, 47.0% for the second group, and 4.2% for placebo.
Also at week 16, the percentage of patients who achieved a PASI 90 was 43.6% in the 400 mg dose group, 35.8% in the 200 mg dose group, and 0.4% in the placebo group.
In CIMPASI-2, 227 mostly white patients with moderate to severe chronic plaque psoriasis, most of whom were in their mid-40s, evenly distributed across the sexes, were randomly assigned to one of three groups. There were 87 participants in the 400 mg every 2 weeks at weeks 0, 2, and 4 group; 91 in the 200 mg every 2 weeks at weeks 0, 2, and 4 arm, and 49 in the placebo group. At week 16, 82.6% of patients in the first group and 81.4% in the second group had a PASI 75, compared with 11.6% of the placebo group. Also at 16 weeks, a PGA scale improvement of at least two points over baseline toward a final score of clear or almost clear skin at week 16 was 71.6% for group 1, 66.8% for the second group, and 2.0% for placebo. At week 16, 55.4% of patients receiving the 400 mg dose had a PASI 90, as did 52.6% of patients receiving the 200 mg dose every 2 weeks, compared with only 4.5% of the placebo group.
Additionally, Dr. Gottlieb said that at week 16, patients in the 400-mg and 200-mg groups showed significant improvements over baseline Dermatology Life Quality Index (DLQI) average scores, compared with placebo: a 10.2 decrease in the 400-mg group and a 9.3 decrease in the 200-mg group, compared with a 3.3 decrease in the placebo arm (P less than .001) in the CIMPASI-1 study. In the CIMPASI-2 study at week 16, there was a drop of 10.0 DLQI in average scores in the 400-mg group, 10.4 in the 200-mg group, and an average drop of only 3.8 in controls (P less than .001).
Dr. Gottlieb, who disclosed that her mother suffers from severe plaque psoriasis, told the audience that the patient improvements were on par with those seen with infliximab, which she said was “the best anti–TNF alpha in the pack to date, and that’s an intravenous drug. These are impressive drops in the DLQI.”
Adverse events were, said Dr. Gottlieb, “a whole lot of nothing. There’s nothing that stands out.” She said there were no cases of tuberculosis, one case of vulvovaginal candidiasis, and equal distribution of herpes zoster across the study.
wmcknight@frontlinemedcom.com
On Twitter @whitneymcknight
AT AAD 17
Key clinical point:
Major finding: In CIMPASI-1, at week 16, the response rate for patients who achieved a PASI 75 was 75.8% in the 400-mg group, 66.5% in the 200-mg group, and 6.5% in the placebo group.
Data source: 461 adults with moderate to severe plaque arthritis randomly assigned to either 400 mg certolizumab pegol, 200 mg of the treatment, or placebo every other week at weeks 0, 2, and 4.
Disclosures: Dr. Gottlieb had relevant disclosures, including with Dermira and UCB, the sponsors of this trial.
VIDEO: Despite promises of abstinence, isotretinoin-exposed pregnancies still occur
ORLANDO – Pregnancy prevention remains a challenge when prescribing isotretinoin to women of childbearing years with acne, Megha M. Tollefson, MD, said at the annual meeting of the American Academy of Dermatology.
Like so many promises having to do with love, a promise of sexual abstinence, however earnest, may at some point fall by the wayside, said Dr. Tollefson of the Mayo Clinic, Rochester, Minn., in a video interview.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Despite the promises, the education, and the allegiance to the iPLEDGE program, exposed pregnancies still occur. iPLEDGE, with a 2.67 rate of fetal exposure over 1,000 treatment courses, was no more effective than its predecessor, SMART, with a 3.11 exposure rate. Altogether, there are still about 150 exposed pregnancies every year; 18 babies were exposed to the drug during SMART and 11 during iPLEDGE.
An anonymous survey of 75 iPLEDGE participants disclosed that 19% of those who chose abstinence were not, and that 34% of those who were sexually active did not comply with the promise to use two forms of birth control.
For some patients, Dr. Tollefson said, the best choice is a patient-independent form of birth control. That’s not an easy conversation to have sometimes, especially when parents are involved, but it’s an important one to have.
Dr. Tollefson had no financial disclosures.
msullivan@frontlinemedcom.com
On Twitter @Alz_Gal
ORLANDO – Pregnancy prevention remains a challenge when prescribing isotretinoin to women of childbearing years with acne, Megha M. Tollefson, MD, said at the annual meeting of the American Academy of Dermatology.
Like so many promises having to do with love, a promise of sexual abstinence, however earnest, may at some point fall by the wayside, said Dr. Tollefson of the Mayo Clinic, Rochester, Minn., in a video interview.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Despite the promises, the education, and the allegiance to the iPLEDGE program, exposed pregnancies still occur. iPLEDGE, with a 2.67 rate of fetal exposure over 1,000 treatment courses, was no more effective than its predecessor, SMART, with a 3.11 exposure rate. Altogether, there are still about 150 exposed pregnancies every year; 18 babies were exposed to the drug during SMART and 11 during iPLEDGE.
An anonymous survey of 75 iPLEDGE participants disclosed that 19% of those who chose abstinence were not, and that 34% of those who were sexually active did not comply with the promise to use two forms of birth control.
For some patients, Dr. Tollefson said, the best choice is a patient-independent form of birth control. That’s not an easy conversation to have sometimes, especially when parents are involved, but it’s an important one to have.
Dr. Tollefson had no financial disclosures.
msullivan@frontlinemedcom.com
On Twitter @Alz_Gal
ORLANDO – Pregnancy prevention remains a challenge when prescribing isotretinoin to women of childbearing years with acne, Megha M. Tollefson, MD, said at the annual meeting of the American Academy of Dermatology.
Like so many promises having to do with love, a promise of sexual abstinence, however earnest, may at some point fall by the wayside, said Dr. Tollefson of the Mayo Clinic, Rochester, Minn., in a video interview.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Despite the promises, the education, and the allegiance to the iPLEDGE program, exposed pregnancies still occur. iPLEDGE, with a 2.67 rate of fetal exposure over 1,000 treatment courses, was no more effective than its predecessor, SMART, with a 3.11 exposure rate. Altogether, there are still about 150 exposed pregnancies every year; 18 babies were exposed to the drug during SMART and 11 during iPLEDGE.
An anonymous survey of 75 iPLEDGE participants disclosed that 19% of those who chose abstinence were not, and that 34% of those who were sexually active did not comply with the promise to use two forms of birth control.
For some patients, Dr. Tollefson said, the best choice is a patient-independent form of birth control. That’s not an easy conversation to have sometimes, especially when parents are involved, but it’s an important one to have.
Dr. Tollefson had no financial disclosures.
msullivan@frontlinemedcom.com
On Twitter @Alz_Gal
AT AAD 17
VIDEO: Gold nanoparticles target laser acne therapy
ORLANDO – There may soon be a new gold standard in acne therapy – gold nanoparticles.
Evidence is mounting that the combination of a laser and a topical suspension of gold- or silver-coated silica nanoparticles can ablate the inner lining of the pilosebaceous unit, dramatically reducing or eliminating acne.
The system is still investigational in the United States, but shows great promise, Gilly Munavalli, MD, said in a video interview at the annual meeting of the American Academy of Dermatology.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Dr. Munavalli, medical director and founder of Dermatology, Laser, and Vein Specialists of the Carolinas, Charlotte, N.C., described how the system works, and some of the evidence supporting it.
“Basically what we’re doing is creating a chromophore for the laser to target,” he said. Just as a laser won’t work on light hair, it can’t target the colorless sebum inside the gland. The colored particles absorb the laser energy, vibrate, and create the locally destructive heat.
The particles are about 150 nm in diameter. They are designed to absorb infrared and near-infrared irradiation. A nanoparticle solution is applied to the affected area. Dr. Munavalli uses an ultrasound paddle to drive the particles into the sebaceous gland, and then removes any solution left on the skin.
He passes a hand-held, 800-nm laser over the skin. The laser activates the particles, generating heat that disrupts the lining of the pilosebaceous unit.
In 2014, Sebacia (Duluth, Ga.), which is developing the technology, reported positive results from two small European trials enrolling a total of 97 patients with acne. The patients were randomized to the gold nanoparticles or to a control group of, in the first study, an over-the-counter face wash and later, the vehicle solution minus the gold nanoparticles.
At 12 weeks’ follow-up, there was a significant reduction in inflammatory lesions and in the Investigator’s Global Assessment score. Treatment was well tolerated and results were durable at 6 months. At that time, the inflammatory lesion count was still 60% below baseline. Side effects were transient erythema and mild edema.
Dr. Munavalli serves as a scientific advisor for Sebacia.
msullivan@frontlinemedcom.com
On Twitter @Alz_Gal
ORLANDO – There may soon be a new gold standard in acne therapy – gold nanoparticles.
Evidence is mounting that the combination of a laser and a topical suspension of gold- or silver-coated silica nanoparticles can ablate the inner lining of the pilosebaceous unit, dramatically reducing or eliminating acne.
The system is still investigational in the United States, but shows great promise, Gilly Munavalli, MD, said in a video interview at the annual meeting of the American Academy of Dermatology.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Dr. Munavalli, medical director and founder of Dermatology, Laser, and Vein Specialists of the Carolinas, Charlotte, N.C., described how the system works, and some of the evidence supporting it.
“Basically what we’re doing is creating a chromophore for the laser to target,” he said. Just as a laser won’t work on light hair, it can’t target the colorless sebum inside the gland. The colored particles absorb the laser energy, vibrate, and create the locally destructive heat.
The particles are about 150 nm in diameter. They are designed to absorb infrared and near-infrared irradiation. A nanoparticle solution is applied to the affected area. Dr. Munavalli uses an ultrasound paddle to drive the particles into the sebaceous gland, and then removes any solution left on the skin.
He passes a hand-held, 800-nm laser over the skin. The laser activates the particles, generating heat that disrupts the lining of the pilosebaceous unit.
In 2014, Sebacia (Duluth, Ga.), which is developing the technology, reported positive results from two small European trials enrolling a total of 97 patients with acne. The patients were randomized to the gold nanoparticles or to a control group of, in the first study, an over-the-counter face wash and later, the vehicle solution minus the gold nanoparticles.
At 12 weeks’ follow-up, there was a significant reduction in inflammatory lesions and in the Investigator’s Global Assessment score. Treatment was well tolerated and results were durable at 6 months. At that time, the inflammatory lesion count was still 60% below baseline. Side effects were transient erythema and mild edema.
Dr. Munavalli serves as a scientific advisor for Sebacia.
msullivan@frontlinemedcom.com
On Twitter @Alz_Gal
ORLANDO – There may soon be a new gold standard in acne therapy – gold nanoparticles.
Evidence is mounting that the combination of a laser and a topical suspension of gold- or silver-coated silica nanoparticles can ablate the inner lining of the pilosebaceous unit, dramatically reducing or eliminating acne.
The system is still investigational in the United States, but shows great promise, Gilly Munavalli, MD, said in a video interview at the annual meeting of the American Academy of Dermatology.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Dr. Munavalli, medical director and founder of Dermatology, Laser, and Vein Specialists of the Carolinas, Charlotte, N.C., described how the system works, and some of the evidence supporting it.
“Basically what we’re doing is creating a chromophore for the laser to target,” he said. Just as a laser won’t work on light hair, it can’t target the colorless sebum inside the gland. The colored particles absorb the laser energy, vibrate, and create the locally destructive heat.
The particles are about 150 nm in diameter. They are designed to absorb infrared and near-infrared irradiation. A nanoparticle solution is applied to the affected area. Dr. Munavalli uses an ultrasound paddle to drive the particles into the sebaceous gland, and then removes any solution left on the skin.
He passes a hand-held, 800-nm laser over the skin. The laser activates the particles, generating heat that disrupts the lining of the pilosebaceous unit.
In 2014, Sebacia (Duluth, Ga.), which is developing the technology, reported positive results from two small European trials enrolling a total of 97 patients with acne. The patients were randomized to the gold nanoparticles or to a control group of, in the first study, an over-the-counter face wash and later, the vehicle solution minus the gold nanoparticles.
At 12 weeks’ follow-up, there was a significant reduction in inflammatory lesions and in the Investigator’s Global Assessment score. Treatment was well tolerated and results were durable at 6 months. At that time, the inflammatory lesion count was still 60% below baseline. Side effects were transient erythema and mild edema.
Dr. Munavalli serves as a scientific advisor for Sebacia.
msullivan@frontlinemedcom.com
On Twitter @Alz_Gal
AT AAD 17
VIDEO: Updating the rule of threes for melanoma gene testing
ORLANDO – The rule of threes that has been used to identify patients at risk of hereditary melanoma who may be candidates for genetic testing may be modified soon, according to Sancy Leachman, MD, PhD, professor and chair of the department of dermatology, Oregon Health and Science University, Portland.
Dr. Leachman was the author of a 2009 study that listed three factors as criteria for identifying melanoma: a personal history of at least three invasive melanomas, a combination of at least three melanomas in the individual and in first-degree and second-degree blood relatives – or, in first- or second-degree relatives, a total of at least three diagnoses of melanoma or pancreatic cancer or astrocytoma, which also have been associated with a known susceptibility gene, p16 (J Am Acad Dermatol. 2009 Oct;61[4]:677.e1-14).
But with more genetic testing, it is becoming clear that there are other cancers associated with an increased risk of hereditary melanoma, she explained in a video interview at the annual meeting of the American Academy of Dermatology. “The genes are a little bit different, but if you could identify those patients, you could potentially then screen them for those other cancers,” said Dr. Leachman, who is also director of the melanoma research program at Knight Cancer Institute at OHSU.
In the interview, she discussed a soon-to-be-published literature review that builds upon the rule of threes and suggests a strategy for deciding which patients should be considered for genetic testing, and includes “a suggested list of genes” that should be used in these different subsets of patients.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Dr. Leachman had no relevant disclosures.
ORLANDO – The rule of threes that has been used to identify patients at risk of hereditary melanoma who may be candidates for genetic testing may be modified soon, according to Sancy Leachman, MD, PhD, professor and chair of the department of dermatology, Oregon Health and Science University, Portland.
Dr. Leachman was the author of a 2009 study that listed three factors as criteria for identifying melanoma: a personal history of at least three invasive melanomas, a combination of at least three melanomas in the individual and in first-degree and second-degree blood relatives – or, in first- or second-degree relatives, a total of at least three diagnoses of melanoma or pancreatic cancer or astrocytoma, which also have been associated with a known susceptibility gene, p16 (J Am Acad Dermatol. 2009 Oct;61[4]:677.e1-14).
But with more genetic testing, it is becoming clear that there are other cancers associated with an increased risk of hereditary melanoma, she explained in a video interview at the annual meeting of the American Academy of Dermatology. “The genes are a little bit different, but if you could identify those patients, you could potentially then screen them for those other cancers,” said Dr. Leachman, who is also director of the melanoma research program at Knight Cancer Institute at OHSU.
In the interview, she discussed a soon-to-be-published literature review that builds upon the rule of threes and suggests a strategy for deciding which patients should be considered for genetic testing, and includes “a suggested list of genes” that should be used in these different subsets of patients.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Dr. Leachman had no relevant disclosures.
ORLANDO – The rule of threes that has been used to identify patients at risk of hereditary melanoma who may be candidates for genetic testing may be modified soon, according to Sancy Leachman, MD, PhD, professor and chair of the department of dermatology, Oregon Health and Science University, Portland.
Dr. Leachman was the author of a 2009 study that listed three factors as criteria for identifying melanoma: a personal history of at least three invasive melanomas, a combination of at least three melanomas in the individual and in first-degree and second-degree blood relatives – or, in first- or second-degree relatives, a total of at least three diagnoses of melanoma or pancreatic cancer or astrocytoma, which also have been associated with a known susceptibility gene, p16 (J Am Acad Dermatol. 2009 Oct;61[4]:677.e1-14).
But with more genetic testing, it is becoming clear that there are other cancers associated with an increased risk of hereditary melanoma, she explained in a video interview at the annual meeting of the American Academy of Dermatology. “The genes are a little bit different, but if you could identify those patients, you could potentially then screen them for those other cancers,” said Dr. Leachman, who is also director of the melanoma research program at Knight Cancer Institute at OHSU.
In the interview, she discussed a soon-to-be-published literature review that builds upon the rule of threes and suggests a strategy for deciding which patients should be considered for genetic testing, and includes “a suggested list of genes” that should be used in these different subsets of patients.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Dr. Leachman had no relevant disclosures.
AT AAD 17
Teledermatology shows potential for grading patch test results
ORLANDO – Store-and-forward teledermatology may be useful for grading patch test results.
Erin Warshaw, MD, and Sara Hylwa, MD, both of the University of Minnesota, Minneapolis, sought to compare readings of patch test results both in person and via store-and-forward teledermatology. They patch tested patients at the Hennepin County (Minn.) Medical Center with the North American Contact Dermatitis Group screening series; photos were obtained at the 48-hour reading and the final reading (96-160 hours).
Almost all (101 of 107) of patients eligible for the trial were enrolled. Patients were overwhelmingly female (72%) with an average age of 50 years in this single-site study. Most screening panels were applied to the back.
Teledermatology assessment was categorized as successful if it matched the in-person assessment and as a failure if it did not; investigators labeled assessed pairs that did not fully match as indeterminate. Successful matches indicated there was no clinically significant difference between teledermatology and in-person assessment, indeterminate matches indicated that there was possible clinically significant difference, and failure to match indicated definite clinically significant difference.
All readings that were negative both in person and via teledermatology were excluded from the analysis.
At 48 hours, 47.2% of 705 reading pairs were labeled successful and 51.3% were labeled indeterminate. Failure, or complete disagreement, occurred in 1.6%, or 11 individual antigen pairs.
More successes – and failures – were seen at the final reading, with 53.8% of 420 final readings labeled successful, 39.8% labeled indeterminate, and 6.4%, or 27 individual antigen pairs, labeled as failures.
In general, teledermatology was more likely to miss or downplay the severity of reactions in the indeterminate pairs, Dr. Warshaw said. “This makes intuitive sense because when you are with a patient live, often the lighting catches an irritant wrinkle reaction or you can feel the lesion and be much more likely to call it irritant or a mild reaction than you would be from a flat photo.”
In the failure group, teledermatology generally overstated reactions, she added.
Dr. Warshaw said that logistical changes would be needed to make teledermatology more effective for reading patch test reactions in her practice. Their method of marking the patch test grid is to use a surgical marker on the corners, but a highlighter to mark the grid between the antigens. The highlighter simply did not show up well in photographs, she noted.
While not perfect, teledermatology does have promise for reading patch test reactions, she added. “I would love to save patients from having to come for their 48-hour reading... In Minnesota we have these horrible snowstorms. Last week there was a blizzard that was predicted. A third of our patients live 2 hours away from the clinic. If they could have taken photographs instead of trying to come through a blizzard for their final reading, that would be helpful.”
Dr. Warshaw noted that their study assessed only the 70 antigens of the North American Contact Dermatitis Research Group series and that it could have been strengthened by using additional series or the patients’ own products.
dfulton@frontlinemedcom.com
On Twitter @denisefulton
ORLANDO – Store-and-forward teledermatology may be useful for grading patch test results.
Erin Warshaw, MD, and Sara Hylwa, MD, both of the University of Minnesota, Minneapolis, sought to compare readings of patch test results both in person and via store-and-forward teledermatology. They patch tested patients at the Hennepin County (Minn.) Medical Center with the North American Contact Dermatitis Group screening series; photos were obtained at the 48-hour reading and the final reading (96-160 hours).
Almost all (101 of 107) of patients eligible for the trial were enrolled. Patients were overwhelmingly female (72%) with an average age of 50 years in this single-site study. Most screening panels were applied to the back.
Teledermatology assessment was categorized as successful if it matched the in-person assessment and as a failure if it did not; investigators labeled assessed pairs that did not fully match as indeterminate. Successful matches indicated there was no clinically significant difference between teledermatology and in-person assessment, indeterminate matches indicated that there was possible clinically significant difference, and failure to match indicated definite clinically significant difference.
All readings that were negative both in person and via teledermatology were excluded from the analysis.
At 48 hours, 47.2% of 705 reading pairs were labeled successful and 51.3% were labeled indeterminate. Failure, or complete disagreement, occurred in 1.6%, or 11 individual antigen pairs.
More successes – and failures – were seen at the final reading, with 53.8% of 420 final readings labeled successful, 39.8% labeled indeterminate, and 6.4%, or 27 individual antigen pairs, labeled as failures.
In general, teledermatology was more likely to miss or downplay the severity of reactions in the indeterminate pairs, Dr. Warshaw said. “This makes intuitive sense because when you are with a patient live, often the lighting catches an irritant wrinkle reaction or you can feel the lesion and be much more likely to call it irritant or a mild reaction than you would be from a flat photo.”
In the failure group, teledermatology generally overstated reactions, she added.
Dr. Warshaw said that logistical changes would be needed to make teledermatology more effective for reading patch test reactions in her practice. Their method of marking the patch test grid is to use a surgical marker on the corners, but a highlighter to mark the grid between the antigens. The highlighter simply did not show up well in photographs, she noted.
While not perfect, teledermatology does have promise for reading patch test reactions, she added. “I would love to save patients from having to come for their 48-hour reading... In Minnesota we have these horrible snowstorms. Last week there was a blizzard that was predicted. A third of our patients live 2 hours away from the clinic. If they could have taken photographs instead of trying to come through a blizzard for their final reading, that would be helpful.”
Dr. Warshaw noted that their study assessed only the 70 antigens of the North American Contact Dermatitis Research Group series and that it could have been strengthened by using additional series or the patients’ own products.
dfulton@frontlinemedcom.com
On Twitter @denisefulton
ORLANDO – Store-and-forward teledermatology may be useful for grading patch test results.
Erin Warshaw, MD, and Sara Hylwa, MD, both of the University of Minnesota, Minneapolis, sought to compare readings of patch test results both in person and via store-and-forward teledermatology. They patch tested patients at the Hennepin County (Minn.) Medical Center with the North American Contact Dermatitis Group screening series; photos were obtained at the 48-hour reading and the final reading (96-160 hours).
Almost all (101 of 107) of patients eligible for the trial were enrolled. Patients were overwhelmingly female (72%) with an average age of 50 years in this single-site study. Most screening panels were applied to the back.
Teledermatology assessment was categorized as successful if it matched the in-person assessment and as a failure if it did not; investigators labeled assessed pairs that did not fully match as indeterminate. Successful matches indicated there was no clinically significant difference between teledermatology and in-person assessment, indeterminate matches indicated that there was possible clinically significant difference, and failure to match indicated definite clinically significant difference.
All readings that were negative both in person and via teledermatology were excluded from the analysis.
At 48 hours, 47.2% of 705 reading pairs were labeled successful and 51.3% were labeled indeterminate. Failure, or complete disagreement, occurred in 1.6%, or 11 individual antigen pairs.
More successes – and failures – were seen at the final reading, with 53.8% of 420 final readings labeled successful, 39.8% labeled indeterminate, and 6.4%, or 27 individual antigen pairs, labeled as failures.
In general, teledermatology was more likely to miss or downplay the severity of reactions in the indeterminate pairs, Dr. Warshaw said. “This makes intuitive sense because when you are with a patient live, often the lighting catches an irritant wrinkle reaction or you can feel the lesion and be much more likely to call it irritant or a mild reaction than you would be from a flat photo.”
In the failure group, teledermatology generally overstated reactions, she added.
Dr. Warshaw said that logistical changes would be needed to make teledermatology more effective for reading patch test reactions in her practice. Their method of marking the patch test grid is to use a surgical marker on the corners, but a highlighter to mark the grid between the antigens. The highlighter simply did not show up well in photographs, she noted.
While not perfect, teledermatology does have promise for reading patch test reactions, she added. “I would love to save patients from having to come for their 48-hour reading... In Minnesota we have these horrible snowstorms. Last week there was a blizzard that was predicted. A third of our patients live 2 hours away from the clinic. If they could have taken photographs instead of trying to come through a blizzard for their final reading, that would be helpful.”
Dr. Warshaw noted that their study assessed only the 70 antigens of the North American Contact Dermatitis Research Group series and that it could have been strengthened by using additional series or the patients’ own products.
dfulton@frontlinemedcom.com
On Twitter @denisefulton
Key clinical point:
Major finding: Teledermatology readings failed to match in-person final readings 6% of the time.
Data source: Single-site study of 101 patients patch tested with the North American Contact Dermatitis Group series.
Disclosures: Dr. Warshaw declared no relevant conflicts of interest.
For bullous pemphigoid, doxycycline noninferior to prednisolone, but safer
ORLANDO – A 6-week course of doxycycline is an effective alternative to prednisolone for initial treatment of bullous pemphigoid in elderly patients, who may be particularly vulnerable to the potentially serious side effects of steroids.
While not as effective or quick-acting as prednisolone, doxycycline effected a cure in 74% of elderly patients who received it for 6 weeks in the Bullous Pemphigoid Steroids and Tetracyclines (BLISTER) Trial. More importantly, however, patients who took the antibiotic experienced half as many serious adverse events as those who took prednisolone (18% vs. 36%), Karen Harman, MD, said at the annual meeting of the American Academy of Dermatology.
The trial results will be published in the March 6 issue of The Lancet, she added.
BLISTER randomized 253 elderly patients with bullous pemphigoid to an initial, 6-week course of either 200 mg doxycycline/day or 0.5 mg/kg prednisolone/day. After the induction period, treatment could be adjusted as needed.
The primary efficacy outcome was blister count at 6 weeks; patients with fewer than three blisters were considered treatment successes. The primary safety outcome was the proportion who experienced an adverse event of at least grade 3 (severe, life-threatening, or fatal) related to the study medication.
The study was conducted at 54 centers in the United Kingdom and Germany, said Dr. Harman, who was also a primary investigator on the trial. It was a pragmatic noninferiority trial.
“We knew from the beginning that doxycycline would not be as effective as prednisolone. We estimated that we would see a 25% reduced efficacy, but we were prepared to accept that if we could also see an improvement in safety of at least 20%.”
Patients were a mean of age of 78 years, although about a quarter were 85 years or older. They scored a mean of 70 points on the 0-100 point Karnofsky scale of functional independence, with 100 being completely functionally independent.
A score of 70 means the patient is capable of self-care but cannot engage in normal activity or work because of disease. About 10% were unable to care for themselves and 42% unable to work.
Over the year-long trial, 33 patients dropped out. The most frequent reason for withdrawal was death – not an unexpected occurrence in such an elderly and infirm group, Dr. Harman noted. There was no significant difference in deaths between the treatment arms. Another 39 withdrew consent during the study. Adverse events caused three patients to drop out (two in the doxycycline group and one in the prednisolone group). One patient taking doxycycline was unable to tolerate the study medication and dropped out.
At 6 weeks, treatment succeeded in 74% of the doxycycline group and in 91% of the prednisolone group. This was an adjusted absolute treatment difference of 18% – well within the 25% margin of noninferiority.
Baseline disease severity didn’t interact with either of the drugs’ effectiveness. Prednisolone was more effective in every severity class. Among those with mild disease, the success rates were 76% with doxycycline and 97% with prednisolone. Among those with moderate disease, success rates were 78% and 97%. Among those with severe disease, both drugs were slightly less effective, with success rates of 65% and 75%.
Adverse events of grade 3 or greater occurred in significantly fewer patients taking doxycycline (18.5% vs. 36.6%), an adjusted difference of 19%. This was close to the 20% gain in safety the investigators hoped for.
Adverse events were common, however, with 82% of patients on doxycycline and 64% on prednisolone experiencing at least one mild-moderate event. Most of these in the doxycycline group were gastrointestinal, Dr. Harman noted.
About twice as many patients taking prednisolone had an event with a maximum of grade 3 (22% vs. 11%). The proportion with a maximum event of grade 4 was 4% in each group. Eleven in the prednisolone group and three in the doxycycline group died (9.7% vs. 2.5%).
The trial had several secondary efficacy outcomes.
Doxycycline had a slower onset of action, as evidenced by the significant difference in high blister count at week 6 (26% vs. 8.7%). At 6 weeks, 20.5% of the doxycycline group and 4% of the prednisolone group experienced treatment failure and chose to switch to the other treatment arm. Adherence was also worse in the doxycycline group, with 19% missing more than 3 consecutive days of treatment vs. 5% in the prednisolone group.
The trial also included a quality of life measure for the entire 52 weeks. Through week 26, this favored prednisolone, again reflecting the slower disease control of doxycycline. Thereafter, quality of life was similar between the two groups.
The trial was run in collaboration with the Nottingham Clinical Trials Unit, the UK Dermatology Clinical Trials Network, and the Medical Research Council Clinical Trials Unit. Dr. Harman had no financial disclosures.
msullivan@frontlinemedcom.com
On Twitter @Alz_Gal
ORLANDO – A 6-week course of doxycycline is an effective alternative to prednisolone for initial treatment of bullous pemphigoid in elderly patients, who may be particularly vulnerable to the potentially serious side effects of steroids.
While not as effective or quick-acting as prednisolone, doxycycline effected a cure in 74% of elderly patients who received it for 6 weeks in the Bullous Pemphigoid Steroids and Tetracyclines (BLISTER) Trial. More importantly, however, patients who took the antibiotic experienced half as many serious adverse events as those who took prednisolone (18% vs. 36%), Karen Harman, MD, said at the annual meeting of the American Academy of Dermatology.
The trial results will be published in the March 6 issue of The Lancet, she added.
BLISTER randomized 253 elderly patients with bullous pemphigoid to an initial, 6-week course of either 200 mg doxycycline/day or 0.5 mg/kg prednisolone/day. After the induction period, treatment could be adjusted as needed.
The primary efficacy outcome was blister count at 6 weeks; patients with fewer than three blisters were considered treatment successes. The primary safety outcome was the proportion who experienced an adverse event of at least grade 3 (severe, life-threatening, or fatal) related to the study medication.
The study was conducted at 54 centers in the United Kingdom and Germany, said Dr. Harman, who was also a primary investigator on the trial. It was a pragmatic noninferiority trial.
“We knew from the beginning that doxycycline would not be as effective as prednisolone. We estimated that we would see a 25% reduced efficacy, but we were prepared to accept that if we could also see an improvement in safety of at least 20%.”
Patients were a mean of age of 78 years, although about a quarter were 85 years or older. They scored a mean of 70 points on the 0-100 point Karnofsky scale of functional independence, with 100 being completely functionally independent.
A score of 70 means the patient is capable of self-care but cannot engage in normal activity or work because of disease. About 10% were unable to care for themselves and 42% unable to work.
Over the year-long trial, 33 patients dropped out. The most frequent reason for withdrawal was death – not an unexpected occurrence in such an elderly and infirm group, Dr. Harman noted. There was no significant difference in deaths between the treatment arms. Another 39 withdrew consent during the study. Adverse events caused three patients to drop out (two in the doxycycline group and one in the prednisolone group). One patient taking doxycycline was unable to tolerate the study medication and dropped out.
At 6 weeks, treatment succeeded in 74% of the doxycycline group and in 91% of the prednisolone group. This was an adjusted absolute treatment difference of 18% – well within the 25% margin of noninferiority.
Baseline disease severity didn’t interact with either of the drugs’ effectiveness. Prednisolone was more effective in every severity class. Among those with mild disease, the success rates were 76% with doxycycline and 97% with prednisolone. Among those with moderate disease, success rates were 78% and 97%. Among those with severe disease, both drugs were slightly less effective, with success rates of 65% and 75%.
Adverse events of grade 3 or greater occurred in significantly fewer patients taking doxycycline (18.5% vs. 36.6%), an adjusted difference of 19%. This was close to the 20% gain in safety the investigators hoped for.
Adverse events were common, however, with 82% of patients on doxycycline and 64% on prednisolone experiencing at least one mild-moderate event. Most of these in the doxycycline group were gastrointestinal, Dr. Harman noted.
About twice as many patients taking prednisolone had an event with a maximum of grade 3 (22% vs. 11%). The proportion with a maximum event of grade 4 was 4% in each group. Eleven in the prednisolone group and three in the doxycycline group died (9.7% vs. 2.5%).
The trial had several secondary efficacy outcomes.
Doxycycline had a slower onset of action, as evidenced by the significant difference in high blister count at week 6 (26% vs. 8.7%). At 6 weeks, 20.5% of the doxycycline group and 4% of the prednisolone group experienced treatment failure and chose to switch to the other treatment arm. Adherence was also worse in the doxycycline group, with 19% missing more than 3 consecutive days of treatment vs. 5% in the prednisolone group.
The trial also included a quality of life measure for the entire 52 weeks. Through week 26, this favored prednisolone, again reflecting the slower disease control of doxycycline. Thereafter, quality of life was similar between the two groups.
The trial was run in collaboration with the Nottingham Clinical Trials Unit, the UK Dermatology Clinical Trials Network, and the Medical Research Council Clinical Trials Unit. Dr. Harman had no financial disclosures.
msullivan@frontlinemedcom.com
On Twitter @Alz_Gal
ORLANDO – A 6-week course of doxycycline is an effective alternative to prednisolone for initial treatment of bullous pemphigoid in elderly patients, who may be particularly vulnerable to the potentially serious side effects of steroids.
While not as effective or quick-acting as prednisolone, doxycycline effected a cure in 74% of elderly patients who received it for 6 weeks in the Bullous Pemphigoid Steroids and Tetracyclines (BLISTER) Trial. More importantly, however, patients who took the antibiotic experienced half as many serious adverse events as those who took prednisolone (18% vs. 36%), Karen Harman, MD, said at the annual meeting of the American Academy of Dermatology.
The trial results will be published in the March 6 issue of The Lancet, she added.
BLISTER randomized 253 elderly patients with bullous pemphigoid to an initial, 6-week course of either 200 mg doxycycline/day or 0.5 mg/kg prednisolone/day. After the induction period, treatment could be adjusted as needed.
The primary efficacy outcome was blister count at 6 weeks; patients with fewer than three blisters were considered treatment successes. The primary safety outcome was the proportion who experienced an adverse event of at least grade 3 (severe, life-threatening, or fatal) related to the study medication.
The study was conducted at 54 centers in the United Kingdom and Germany, said Dr. Harman, who was also a primary investigator on the trial. It was a pragmatic noninferiority trial.
“We knew from the beginning that doxycycline would not be as effective as prednisolone. We estimated that we would see a 25% reduced efficacy, but we were prepared to accept that if we could also see an improvement in safety of at least 20%.”
Patients were a mean of age of 78 years, although about a quarter were 85 years or older. They scored a mean of 70 points on the 0-100 point Karnofsky scale of functional independence, with 100 being completely functionally independent.
A score of 70 means the patient is capable of self-care but cannot engage in normal activity or work because of disease. About 10% were unable to care for themselves and 42% unable to work.
Over the year-long trial, 33 patients dropped out. The most frequent reason for withdrawal was death – not an unexpected occurrence in such an elderly and infirm group, Dr. Harman noted. There was no significant difference in deaths between the treatment arms. Another 39 withdrew consent during the study. Adverse events caused three patients to drop out (two in the doxycycline group and one in the prednisolone group). One patient taking doxycycline was unable to tolerate the study medication and dropped out.
At 6 weeks, treatment succeeded in 74% of the doxycycline group and in 91% of the prednisolone group. This was an adjusted absolute treatment difference of 18% – well within the 25% margin of noninferiority.
Baseline disease severity didn’t interact with either of the drugs’ effectiveness. Prednisolone was more effective in every severity class. Among those with mild disease, the success rates were 76% with doxycycline and 97% with prednisolone. Among those with moderate disease, success rates were 78% and 97%. Among those with severe disease, both drugs were slightly less effective, with success rates of 65% and 75%.
Adverse events of grade 3 or greater occurred in significantly fewer patients taking doxycycline (18.5% vs. 36.6%), an adjusted difference of 19%. This was close to the 20% gain in safety the investigators hoped for.
Adverse events were common, however, with 82% of patients on doxycycline and 64% on prednisolone experiencing at least one mild-moderate event. Most of these in the doxycycline group were gastrointestinal, Dr. Harman noted.
About twice as many patients taking prednisolone had an event with a maximum of grade 3 (22% vs. 11%). The proportion with a maximum event of grade 4 was 4% in each group. Eleven in the prednisolone group and three in the doxycycline group died (9.7% vs. 2.5%).
The trial had several secondary efficacy outcomes.
Doxycycline had a slower onset of action, as evidenced by the significant difference in high blister count at week 6 (26% vs. 8.7%). At 6 weeks, 20.5% of the doxycycline group and 4% of the prednisolone group experienced treatment failure and chose to switch to the other treatment arm. Adherence was also worse in the doxycycline group, with 19% missing more than 3 consecutive days of treatment vs. 5% in the prednisolone group.
The trial also included a quality of life measure for the entire 52 weeks. Through week 26, this favored prednisolone, again reflecting the slower disease control of doxycycline. Thereafter, quality of life was similar between the two groups.
The trial was run in collaboration with the Nottingham Clinical Trials Unit, the UK Dermatology Clinical Trials Network, and the Medical Research Council Clinical Trials Unit. Dr. Harman had no financial disclosures.
msullivan@frontlinemedcom.com
On Twitter @Alz_Gal
Key clinical point:
Major finding: At 6 weeks, treatment succeeded in 74% of the doxycycline group and 91% of the prednisolone group; severe adverse events occurred in 18% and 36%, respectively.
Data source: The BLISTER trial randomized 253 patients.
Disclosures: The trial was run in collaboration with the Nottingham Clinical Trials Unit, the UK Dermatology Clinical Trials Network, and the Medical Research Council Clinical Trials Unit. Dr. Harman had no financial disclosures.